【摘要】 目的优选复方卡森颗粒最佳的制剂成型工艺,并建立可靠的质量控制方法。方法以成型性、吸湿性、溶化性、堆密度及休止角为指标综合评价,优化复方卡森颗粒的最佳赋形剂和比例及润湿剂种类和用量;采用薄层色谱（TLC）法对玫瑰花、小茴香进行定性鉴别;采用高效液相色谱（HPLC）法测定制剂中没食子酸的含量。结果复方卡森颗粒最佳赋形剂比例为干膏粉:乳糖:糊精为2:1:1,75%乙醇适量,所制得的颗粒成型性、溶化性和抗湿性均好;薄层色谱斑点清晰,分离良好,阴性无干扰,专属性强;没食子酸在浓度为11.25～89.97μg·mL^-1范围内,与峰面积呈良好的线性关系,相关系数r=0.999 9;平均回收率为92.74%,RSD=0.79%（n=6）。结论该工艺可靠稳定,重复性好,所制颗粒符合《中华人民共和国药典》 2020年版四部"颗粒剂"项下要求;建立的TLC和HPLC方法专属性强、灵敏度高、重复性好,可用于复方卡森颗粒剂的质量控制。更多还原

【Abstract】 Objective To optimize the best formulation process and establish the quality standard for Compound kasen granules. Methods Taking the formability, hygroscopicity, solubility, bulk density, and angle of repose of the particles as the comprehensive evaluation indicators, the optimal excipient and proportion, wetting agent type, and the amount of compound kasen granules were optimized.Rosa rugosa flos and Foeniculi fructus were qualitatively identified by a thin layer chromatography（TLC）.The content of gallic acid in compound Kasen granules was determined by a high performance liquid chromatography（HPLC）. Results The best excipient proportion of Compound kasen granules was that dry paste powder: lactose: dextrin was 2:1:1,and wetting agent was 75% ethanol.According to this formulation process, the particles have good formability, solubility, and moisture resistance.The results of TLC showed that the relevant spots were clear, well separated, and negative without interference.The TLC method was highly specific.Gallic acid concentration graph showed a good linear relationship at a range of 11.25-89.97 μg·mL^-1（r=0.999 9）.The average recovery rate was 92.47%,RSD=0.79%（n=6）. Conclusion The process was reliable, stable, and reproducible.The granules met the requirements for “granules” in the fourth part of Pharmacopoeia of the Peoples Republic of China（2020 Edition）.The established TLC and HPLC methods in this study are highly specific and sensitive with good reproducibility, and can be effectively used for the quality control of Compound kasen granules.更多还原